Spineology PEEK Lumbar Interbody Fusion Device
FDA 510(k) K123652 · Spineology, Inc.
510(k) numberK123652
Submission
- Device name
- Spineology PEEK Lumbar Interbody Fusion Device
- Applicant
- Spineology, Inc.
Saint Paul, MN, US - Received
- November 27, 2012
- Decision date
- March 22, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code MAX
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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional | 12/15/2025SE |
| K251943 | Spineology Navigation InstrumentsOLO · Special | 12/04/2025SE |
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional | 11/01/2023SE |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Special | 10/18/2023SE |
| K213876 | Spineology Navigation InstrumentsOLO · Traditional | 08/05/2022SE |
| K210155 | Duo Expandable Interbody Fusion SystemMAX · Special | 02/19/2021SE |
| K192047 | Rampart One Lumbar Interbody Fusion SystemOVD · Special | 08/23/2019SE |
| K191091 | Rampart One Lumbar Interbody Fusion SystemOVD · Special | 05/23/2019SE |
| K190055 | Duo Lumbar Interbody Fusion DeviceMAX · Special | 03/07/2019SE |
| K182322 | Duo Lumbar Interbody Fusion DeviceMAX · Traditional | 10/24/2018SE |
Questions and answers
When was Spineology PEEK Lumbar Interbody Fusion Device cleared by the FDA?
Spineology PEEK Lumbar Interbody Fusion Device (K123652) received a 510(k) decision of Substantially Equivalent on March 22, 2013, 115 days after the submission was received.
What is the product code of K123652?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.